Sunscreening Agents
Conditions
Brief summary
To determine the phototoxic potential of a topically applied article in human subjects.
Interventions
DRUGSunscreen Sport Spray (BAY987519)
50 μl/cm\*2 or 0.05 gm/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm\*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB#Y51-002)
OTHERUntreated Skin
This site is patched without treatment as irradiated control.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Be male or female between the ages of 18 and 60 inclusive; * Be lightly pigmented (Fitzpatrick Skin Type I, II, III); * Have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164; * Be in general good health as determined by the subject's medical history and in the discretion of the investigator.
Exclusion criteria
* Have a visible sunburn; * Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of skin reactions will be evaluated using 5 point grading scale. | Up to 48 hours |
Countries
United States
Outcome results
None listed